Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients. (A7881010)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00783406
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : November 1, 2010
Information provided by:

Brief Summary:
This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: PF-00610355 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.
Study Start Date : October 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: PF- 00610355 Drug: PF-00610355
dry powder inhaler, 1472 mcg, single dose

Experimental: PF-00610355 Drug: PF-00610355
dry powder inhaler, 736 mcg, single dose

Experimental: PF -00610355 Drug: PF-00610355
dry powder inhaler, 368 mcg, single dose

Placebo Comparator: Placebo Drug: Placebo

Primary Outcome Measures :
  1. To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients. [ Time Frame: up to 8 days post dose ]
  2. To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients [ Time Frame: up to 24 hours post dose ]

Secondary Outcome Measures :
  1. To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients. [ Time Frame: up to 24 hours post dose ]
  2. To investigate the exposure/response relationship of PF-00610355. [ Time Frame: up to 8 days post dose ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Post-bronchodilator FEV1/ FVC ratio of <0.7.
  • Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
  • Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
  • Current smokers, or ex-smokers who have abstained from smoking for at least 6 months.

Exclusion Criteria:

  • Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
  • History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00783406

Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Wiesbaden, Germany, 65187
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00783406     History of Changes
Other Study ID Numbers: A7881010
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: November 1, 2010
Last Verified: October 2010

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive